510(k) Report

Devices descending from P960025

1,714 later devices reach Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+4K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+4K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+4K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+4K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+4K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K182721Choice Spine Navigation SystemChoicespine, LP20192—
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K182584Lucent® XPSpinal Elements, Inc.20183—
+4K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+4K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+4K181829Velofix TLIF CageU&I Corporation20181—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+4K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+4K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+4K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+4K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+4K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+4K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+4K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+4K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+4K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+4K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+4K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+4K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+4K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+4K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+4K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+4K173022SeaSpine Ventura NanoMetalene SystemSeaSpine Orthopedics Corporation20170—
+4K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+4K172065Scarlet AC-TSpineart20172—
+4K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+4K171704CAPRI Corpectomy Cage SystemK2m201710—
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+4K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+4K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+4K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+4K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+4K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+4K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+4K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+4K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+4K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+4K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+4K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+4K162531Sterispine CCSafe Orthopaedics20160—
+4K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+4K162262Tritanium® PL CageStryker2016132—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura…SeaSpine Orthopedics Corporation2016103—
+4K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+4K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+4K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+4K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+4K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+4K160955Tritanium® PL CageStryker2016178—
+4K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+4K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+4K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+4K160291Optimus ALIF SystemAmendia, Inc.20160—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+4K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+4K152651AccuLIF TL and PL CageStryker Corporation201530—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+4K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+4K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+4K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+4K151654Prow FusionNlt Spine, Ltd.20151—